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Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial. (DEFINITION)

Primary Purpose

Radial Artery Occlusion

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Unfractionated Heparin
Sponsored by
Instituto Nacional de Cardiologia Ignacio Chavez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radial Artery Occlusion focused on measuring Radial Artery Occlusion, Percutaneous coronary intervention, Transradial access, Unfractionated Heparin, Coronary angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years of age, both genders.
  • Successful transradial acess for an elective diagnostic coronary angiography.

Exclusion Criteria:

  • Weight <50 Kg
  • Puncture of the ipsilateral radial artery in the last month.
  • Still ongoing effect of pre-procedural recently used oral anticoagulants.
  • Use of enoxaparin in the past in the last 12 hours prior to the procedure.
  • Use of unfractionated heparin in the last 6 hours prior the procedure
  • Alterations in coagulation or platelets prone to bleeding or thrombotic complications.
  • Anatomical alterations at the radial access site or radial artery.
  • Arteriovenous fistula in the ipsilateral arm.
  • History of major bleeding associated with the use of UFH.

Sites / Locations

  • Instituto Nacional de Cardiología Ignacio ChávezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Dose of Unfractionated Heparin

Standard Dose of Unfractionated Heparin

Arm Description

100 IU/Kg of Unfractionated Heparin

5000 IU of Unfractionated Heparin.

Outcomes

Primary Outcome Measures

Radial artery occlusion (RAO).
The incidence of RAO (with DUS and plethysmography).
Radial artery occlusion (RAO).
The incidence of RAO (with DUS and plethysmography).

Secondary Outcome Measures

Time to hemostasis.
Time to hemostasis, from the removal of the introducer sheath to hemostasis.
Diameters of the radial artery.
Minimum, maximum and mean diameters of the radial artery by vascular ultrasound.
Correlation of RAO by oximetric plethysmography and DUS.
Correlation of plethysmography and DUS for the determination of RAO.
Hemorrhagic Complications.
Compare the incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: The BARC-2 scale: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5
Hemorrhagic Complications.
Compare the incidence of bleeding complications according to the Early Discharge After Transradial Stenting of Coronary Arteries Study (EASY) scale: The EASY scale: Grade I Grade II Grade III Grade IV Grade V

Full Information

First Posted
September 11, 2020
Last Updated
October 14, 2022
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
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1. Study Identification

Unique Protocol Identification Number
NCT04561648
Brief Title
Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial.
Acronym
DEFINITION
Official Title
Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Double blind single center clinical trial to compare the incidence of radial artery occlusion (RAO) using standard doses of Unfractionated Heparin (UFH) vs. high doses of UFH.
Detailed Description
Radial artery occlusion (RAO) is one of the most common complications in transradial artery interventions (up to 30% of cases if specific measures are not taken to prevent it) and is related to the prothrombotic state of the patient, the scarce distal flow to the access site and the trauma caused to the artery during the procedure. Currently worldwide, the transradial (TRA) access is the most widely used access for coronary angiography (in up to 90% of the procedures) because the transradial approach is associated with lower rates of vascular complications and event mortality (compared to the femoral access). Although TRA access is safer, it is not free of complications, being one of the most important the RAO. There are universal efforts to reduce RAO improving every aspects of the technique, from the type of introducer to the hemostasis time to a distal TRA, with evidence suggesting that higher doses of UFH can also decrease RAO to a greater extent. The decrease in the incidence of RAO have been proposed to be up to 2.8 times with high doses of UFH (single-center, retrospective study that compared regular not standard doses of UFH versus higher doses of UFH) although no proper prospective clinical trial have been undertaken to prove this. The standard dose that has shown a lower rate of RAO is 5000 IU, which will be compared with 100 IU / Kg of UFH, with a randomized, prospective, double-blind design, with short-term (24-hour) follow-up with Doppler ultrasound (DUS) and its correlation with plethysmography to document RAO, and in occluded arteries, there will be a 30-day follow-up to determine the recanalization (or persistent occlusion) rates by DUS (and plethysmography). In order to address safety concerns of higher UFH doses, all the potential hemorrhagic complications will be evaluated during the study follow-up time and higher hemorrhagic risk patients are going to be excluded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radial Artery Occlusion
Keywords
Radial Artery Occlusion, Percutaneous coronary intervention, Transradial access, Unfractionated Heparin, Coronary angiography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients that are planned to go to an invasive coronary artery angiography with good radial pulse and using the TRA are going to be randomized to two groups. One will receive the standard UFH dose and the other will receive the prespecified high dose (per Kg of body weight) of UFH.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1988 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Dose of Unfractionated Heparin
Arm Type
Experimental
Arm Description
100 IU/Kg of Unfractionated Heparin
Arm Title
Standard Dose of Unfractionated Heparin
Arm Type
Active Comparator
Arm Description
5000 IU of Unfractionated Heparin.
Intervention Type
Drug
Intervention Name(s)
Unfractionated Heparin
Intervention Description
Before removing the introducer sheath, the 2nd operator will pass the missing UFH dose to the first operator to reach 100 IU per kg of body weight in a 10 ml syringe mixed with 0.9% saline solution. The blinded first operator will administer this without knowing if it is saline or the supplemental dose of unfractionated heparin.
Primary Outcome Measure Information:
Title
Radial artery occlusion (RAO).
Description
The incidence of RAO (with DUS and plethysmography).
Time Frame
24 hours.
Title
Radial artery occlusion (RAO).
Description
The incidence of RAO (with DUS and plethysmography).
Time Frame
30 days.
Secondary Outcome Measure Information:
Title
Time to hemostasis.
Description
Time to hemostasis, from the removal of the introducer sheath to hemostasis.
Time Frame
24 hours.
Title
Diameters of the radial artery.
Description
Minimum, maximum and mean diameters of the radial artery by vascular ultrasound.
Time Frame
24 hours.
Title
Correlation of RAO by oximetric plethysmography and DUS.
Description
Correlation of plethysmography and DUS for the determination of RAO.
Time Frame
30 days.
Title
Hemorrhagic Complications.
Description
Compare the incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: The BARC-2 scale: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5
Time Frame
30 days.
Title
Hemorrhagic Complications.
Description
Compare the incidence of bleeding complications according to the Early Discharge After Transradial Stenting of Coronary Arteries Study (EASY) scale: The EASY scale: Grade I Grade II Grade III Grade IV Grade V
Time Frame
24 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age, both genders. Successful transradial acess for an elective diagnostic coronary angiography. Exclusion Criteria: Weight <50 Kg Puncture of the ipsilateral radial artery in the last month. Still ongoing effect of pre-procedural recently used oral anticoagulants. Use of enoxaparin in the past in the last 12 hours prior to the procedure. Use of unfractionated heparin in the last 6 hours prior the procedure Alterations in coagulation or platelets prone to bleeding or thrombotic complications. Anatomical alterations at the radial access site or radial artery. Arteriovenous fistula in the ipsilateral arm. History of major bleeding associated with the use of UFH.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monserrat Villalobos Pedroza, M.D.
Phone
55 5573 2911
Ext
21217
Email
movspa@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guering Eid Lidt, M.D.
Phone
55 5573 2911
Ext
21217
Email
guering@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guering Eid Lidt, M.D.
Organizational Affiliation
Instituto Nacional de Cardiología Ignacio Chávez
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Julio I Farjat Pasos, M.D.
Organizational Affiliation
Instituto Nacional de Cardiología Ignacio Chávez
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Aguila Bravo, M.D.
Organizational Affiliation
Instituto Nacional de Cardiología Ignacio Chávez
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monserrat Villalobos Pedroza, M.D.
Organizational Affiliation
Instituto Nacional de Cardiología Ignacio Chávez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Cardiología Ignacio Chávez
City
Mexico City
State/Province
Tlalpan
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monserrat Villalobos, M.D.
Phone
55 5573 2911
Ext
21217
Email
movspa@hotmail.com
First Name & Middle Initial & Last Name & Degree
Guering Edit Lid, M.D.
Phone
55 5573 2911
Ext
21217
Email
guering@yahoo.com
First Name & Middle Initial & Last Name & Degree
Carlos A Aguila Bravo, M.D.
First Name & Middle Initial & Last Name & Degree
María E Soto López, M.D.
First Name & Middle Initial & Last Name & Degree
Jorge Gaspar, M.D

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The individual patient data will not be shared with other researchers.

Learn more about this trial

Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial.

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